Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin

Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment
of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

CHICAGO, Sept. 26, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX), an emerging specialty pharmaceutical company, today announced
that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) seeking approval for the marketing and sale of
dalbavancin for the treatment of patients with acute bacterial skin and skin
structure infections (ABSSSI) caused by susceptible Gram-positive
microorganisms, including MRSA (methicillin resistant Staphylococcus aureus).

"We are pleased to be another step closer to offering dalbavancin for the
treatment of patients with acute bacterial skin and skin structure
infections," said Paul R. Edick, Durata Therapeutics Chief Executive Officer.
"Dalbavancin is our first product candidate, and this milestone demonstrates
our company's commitment to improving patients' lives by addressing the
growing demand for therapeutics to treat acute illnesses and infectious
diseases."

The submission is based on the entire data set from Durata Therapeutics'
clinical development program, including positive results from two Phase 3
trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study
(VER-009). Both DISCOVER 1 and DISCOVER 2 trials were conducted under a
Special Protocol Assessment (SPA) with the FDA.

In November 2012, the FDA designated dalbavancin as a Qualified Infectious
Disease Product (QIDP). The QIDP provides Durata Therapeutics priority review
by the FDA, eligibility for fast-track status, and extension of statutory
exclusivity periods for an additional five years upon FDA approval of the
product.

"Currently available treatments for ABSSSI have limitations, especially in
today's health care environment, so the development of new antibiotics is
imperative," said David Andrew Talan, MD, FACEP, FIDSA Chairman, Department of
Emergency Medicine and Faculty, Division of Infectious Diseases. "If approved
by the FDA, dalbavancin, with its once-weekly 30-minute intravenous doses, may
help facilitate an important shift in treatment from the hospital to
ambulatory settings."

ABOUT ABSSSI

For the six month period of January to June 2010, a projected 9.2 million
patients were treated in U.S. hospitals for infections of any type, and nearly
17 percent of the diagnostic category presentations were for skin and skin
structure infections (SSSIs). Of these presentations for SSSI, approximately
74 percent were disease types included in ABSSSI.^i This category of infection
increased by 176 percent from 1997 to 2009 in hospitalized patients.^ii The
majority of skin and soft tissue infections in hospitalized patients are
caused by Staphylococcus aureus, and approximately 59 percent of these
infections are estimated to be caused by MRSA in the U.S.^iii,iv Effective
early treatment of ABSSSI is critical to prevent wound expansion and to avoid
lengthy and costly hospital stays.^v Failure to successfully treat ABSSSI may
result in hospital readmissions. Under the new health care reform laws,
hospitals may incur financial penalties for preventable hospital readmissions,
including unresolved infections.

ABOUT DALBAVANCIN

Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which
consists of lipophilic side-chains attached to glycopeptides. When compared to
vancomycin, dalbavancin has a longer half-life resulting in a duration of
antibacterial activity of 5-7 days per dose.^viIf approved, dalbavancin
would be the first drug for ABSSSI requiring once-weekly 30-minute intravenous
doses (1000 mg on Day 1 and 500 mg on Day 8). This may allow for the treatment
of patients with ABSSSI in both inpatient and outpatient settings—potentially
shortening the length of patient hospital stays, or in some cases, eliminating
hospital admissions altogether.^vii Ultimately, this may lower the overall
cost of care for these patients.

ABOUT DURATA THERAPEUTICS, INC.

Durata Therapeutics, Inc. is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for patients with
infectious diseases and acute illnesses. Durata has completed two global Phase
3 clinical trials with its lead product candidate, dalbavancin, for the
treatment of patients with acute bacterial skin and skin structure infections,
or ABSSSI.

FORWARD-LOOKING STATEMENTS

Statements contained in this press release contain forward-looking statements
that involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.

Forward-looking statements in this press release include statements about the
FDA approval of dalbavancin and the potential impact of dalbavancin's dosing
schedule on hospital costs and readmissions. Actual results may differ
materially from those indicated by these forward-looking statements as a
result of various important factors, including those discussed in the "Risk
Factors" section of our most recent quarterly report on Form 10-Q, which is on
file with the SEC and is also available on our website. In addition, any
forward-looking statements represent our views only as of today and should not
be relied upon as representing our views as of any subsequent date. While we
may elect to update these forward-looking statements at some point in the
future, we specifically disclaim any obligation to do so, even if our views
change. Therefore, you should not rely on these forward-looking statements as
representing our views as of any date subsequent to today.

^i AMR Hospital Antibiotic Market Guide - Book 2: Diagnosis and Surgery
Reports, January 2010 – June 2010.

^ii Giuliano C, Kale-Pradhan P, et al. Early Response of Ceftaroline Fosamil
in the Treatment of Soft-tissue Infections. Expert Rev Clin Pharmacol.
5(5):509-512(2012).

^iii Moet G, Jones R, et al. Contemporary causes of skin and soft tissue
infections in North America, Latin America and Europe: Report from the SENTRY
Antimicrobial Surveillance Program (1998-2004). Diagnostic Microbiology and
Infectious Disease. 57, 7-13 (2007).

^iv Moran GJ, Krishnadasan A, Gorwitz RJ et al.; EMERGEncy ID Net Study Group.
Methicillin-resistant S. aureus infections among patients in the emergency
department. N. Engl. J. Med. 355(7), 666–674(2006).

^v Parta M, M Goebel et al. Impact of an Assay That Enables Rapid
Determination of Staphylococcus Species and Their Drug Susceptibility on the
Treatment of Patients with Positive Blood Culture Results. Infect. Control and
Hospital Epidemiology. 31(10),1043-1048(2010).

^vi Durata DOF.

^vii Durata Therapeutics website. About dalbavancin.
http://www.duratatherapeutics.com/product-pipeline/dalbavancin/overview
(Durata DOF)

CONTACT: Investor Relations and Public Affairs Contact
         Allison Wey
         Durata Therapeutics
         Vice President, Investor Relations and Public Affairs
         (312) 219-7017
         awey@duratatherapeutics.com
        
         Media Relations Contact
         Geoff Curtis
         DJE Science
         (312) 233-1253
         geoff.curtis@djescience.com

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